2hr18 3-0 U Mnd 16x16 13mm Ldr RS-1001QRecalls & reported problems
Surgical Specialties México, S. de R.L. de C.V. · 2hr18 3-0 U Mnd 16x16 13mm Ldr · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00848782019366), received between Dec 12, 2024 and Dec 12, 2024 — classified as 2 injuries.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Wound Dehiscence2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryDec 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON (B)(6) 2024 IT WAS REPORTED THAT WOUND DEHISCENCE RESULTED IN ANASTOMOSIS OF THE URETHRA AND BLADDER.
Patient problems: Wound Dehiscence
MAUDE report 20919999 ↗InjuryDec 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON (B)(6) 2024 IT WAS REPORTED THAT WOUND DEHISCENCE RESULTED IN ANASTOMOSIS OF THE URETHRA AND BLADDER.
Patient problems: Wound Dehiscence
MAUDE report 20918623 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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